Vol. 18, Special Issue, July, 2005 - the American Journal of Dentistry

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_____________________________________________________________________________________________________________________________________ Research Article _____________________________________________________________________________________________________________________________________ Practice implications with an alcohol-free, 0.07% cetylpyridinium chloride mouthrinse TRACIE V. BLENMAN, BS, KELLY L. MORRISON, MED, GRACE J. TSAU, BS ANA L. MEDINA, MS & ROBERT W. GERLACH, DDS, MPH ABSTRACT: Purpose: Behavioral research was conducted to ascertain the relevance of an alcohol-free, 0.07% cetylpyridinium chloride (CPC) therapeutic mouthrinse to contemporary dental practice over a 6-month usage period. Methods: A randomized, single-blind study was conducted to assess practice-relevant compliance, acceptability and side effects associated with two mouthrinses. The target population was healthy adult mouthrinse users with a history of routine dental prophylaxis and maintenance care. Subjects were randomly assigned to a therapeutic mouthrinse with 0.07% CPC (Crest Pro-Health Rinse) or a cosmetic rinse control (Scope). Other oral hygiene was not standardized. Subjects completed a questionnaire and were examined by dental hygienists at baseline, and again after 3 and 6 months rinsing. At study completion, a dental prophylaxis was administered. Results: Compliance was generally favorable, with 273 subjects (89%) completing the 6-month rinsing study. Rinsing time generally stayed the same or increased relative to baseline. Groups differed among the subset who historically used an essential oils rinse (N=137), where those assigned to the alcohol-free therapeutic rinse exhibited significantly (P= 0.02) longer rinsing times compared to subjects using the alcohol-containing cosmetic rinse. Subject evaluations were generally positive with respect to both rinses. Side effects were minimal, with no between-group differences in hygienist-rated calculus or stain accumulation, or prophylaxis time. (Am J Dent 2005;18: 29A-34A). CLINICAL SIGNIFICANCE: In a 6-month study, a high bioavailable 0.07% CPC therapeutic mouthrinse showed generally high compliance and favorable user acceptability, with similar side effects to those seen with a cosmetic mouthrinse. These findings suggest that the 0.07% CPC mouthrinse may be readily incorporated within the contemporary recall dental practice. �: Dr. Robert W. Gerlach, Worldwide Clinical Investigations – Oral, The Procter and Gamble Company, 8700 Mason- Montgomery Road, Mason, Ohio 45040-9462, USA. E-�: gerlach.rw@pg.com Introduction The role of therapeutic rinses in the prevention and treatment of periodontal diseases has been long recognized. 1 Various antiseptics have been used in mouthrinse formulations, including bisbiguanides, essential oils, quarternary ammoniums and others. 2 Many of these agents are also found in other consumer goods, such as cleansers or deodorants. In rinses, these agents are commonly formulated with alcohol, not for any direct therapeutic reasons, but to help solubilize or disperse active ingredients or flavor oils. 3,4 Prominent clinical benefits include reductions in plaque or gingivitis attributable to immediate or sustained antimicrobial activity. Usage may be short term (especially with chlorhexidine) or as a routine part of daily oral hygiene. There is considerable clinical trial evidence of the plaque and gingivitis benefits seen with therapeutic rinses relative to conventional toothbrushing. 5 Interestingly, delivery of therapeutic agents via rinse may offer some advantages over dentifrices. For example, use of an essential oils mouthrinse with routine toothbrushing is reported to yield better improvements in plaque, relative to a triclosan-containing anticavity dentifrice. 6 Ease of dispersion may contribute to some of the benefits, as evidenced by the malodor effects reported with some therapeutic mouthrinses. 7,8 Relative to antibiotics, the common antiseptic rinses are recognized as having a generally lower incidence of adverse events, with little potential for resistance development, and demonstrated safety for routine use. 2 Except for isolated case reports involving mouthrinse abuse or accidental misuse, 9 serious adverse events are virtually unknown. Clinical oral soft tissue effects are reported to not differ from normal controls. 10 Common side effects with therapeutic rinses include temporary taste alteration, superficial tooth staining, and calculus accumulation. Of these, taste alteration may be the most common. The phenomenon is reported for rinses containing chlorhexidine, essential oils, and cetylpyridinium chloride (CPC), among others. 6,11-14 Except for chlorhexidine, 15 taste perturbation is transient, with few-to-no reports of long term taste alteration. Other taste effects may be immediate, for example, the bitter taste or a burning sensation reported with some alcohol-containing formulations. 11,12 Extrinsic tooth stain has been reported for chlorhexidine, delmopinol, CPC, and essential oils, among others. 12,16-19 Comparative trials usually show greatest stain accumulation with chlorhexidine compared to other antiseptics. Under certain conditions, this staining may be manifested after only a few days, with diet and other behaviors likely contributing to the extent and/or severity of staining. 20,21 In addition, supragingival calculus accumulation has been reported with some therapeutic rinses, most commonly for those containing chlorhexidine, and rarely, others. 16,17,22,23 Periodic treatment of stain and calculus accumulation is typically limited to routine dental prophylaxis. Along with taste, implications are primarily around rinsing compliance, especially with long term use. Previous research has shown rinse formulation to impact on clinical effectiveness. CPC is a popular broad-spectrum antimicrobial that penetrates bacterial cell membranes, lead-
30A Blenman et al ing to cellular lysis, metabolic disruption, growth inhibition, and cell death. 24 Differences in rinse formulation may contribute nearly a two-fold increase in available concentration of CPC relative to Scope a or Cepacol b where CPC is less available. 25 Research has shown that formulations with high bioavailable CPC are associated with greater biological activity. 25 Based on these findings, an alcohol-free, CPC mouthrinse has been developed with a poloxamer emulsifier in order to increase bioavailability. 4 The formulation was designed to have a pleasing in-use experience, specifically no alcohol-burn, to enhance compliance. This high bioavailable, alcohol-free 0.07% CPC mouthrinse has been shown to yield significant antiplaque and antigingivits benefits, similar in magnitude when compared to a positive control containing alcohol and essential oils. 26 Other controlled clinical trials report antiplaque or antigingivitis benefits with highly available CPC used for periods of up to 6 months. 27,28 These findings contrast with those previously reported for low available CPC when delivered using a highly flavored, cosmetic rinse. 29 This new research was designed to ascertain the relevance of a novel, alcohol-free therapeutic mouthrinse to clinical practice. Subjects were randomly supplied with the new therapeutic mouthrinse or a cosmetic mouthrinse control. Dental hygienists were asked to evaluate response as part of routine prophylaxis maintenance care. The research investigated the following questions relative to an accepted rinse control: �� Would dental patients comply with therapeutic rinsing over an extended period? �� Is the rinse acceptable, or does taste or perception impact on usage? �� What are the common side effects, and impact on long term usage? Materials and Methods A randomized, single-blind study was conducted to assess practice-relevant compliance, acceptability and side effects associated with two mouthrinses. The target population was healthy adult volunteers who routinely used mouthrinses. Study subjects were randomly assigned to a therapeutic mouthrinse (Crest Pro-Health Rinse a ), or a cosmetic mouthrinse control (Scope). Treatment was unsupervised over a 6-month period. A contract research organization recruited potential subjects from the general population in the greater Indianapolis, Indiana, USA area. The enrollment target was up to 300 subjects, to ensure at least 130 per group at study completion. Candidate subjects were screened by telephone to ascertain habits and oral hygiene practices. Eligibility was limited to generally healthy adults, 18-65 years of age, who routinely used a cosmetic or therapeutic mouthrinse (any type). Patients of record (having a history of routine dental care) were specifically targeted, with enrollment limited to individuals who had a routine dental prophylaxis within the previous 12 months. Subjects were excluded due to edentulism, presence of orthodontic devices, history of alcohol abuse, tobacco use exceeding 1 pack per day, or need for prophylactic antibiotic therapy prior to dental treatment. At baseline, written and verbal informed consent was obtained, a baseline questionnaire was administered, oral health status was evaluated by a dental hygienist, and intraoral American Journal of Dentistry, Vol. 18, Special Issue, July, 2005 photographs were obtained using standard methods. Study subjects were then randomly assigned to one of two mouthrinses, balancing for rinsing behavior, tobacco use, coffee/tea consumption, and dentifrice type (regular or antitartar). After 3 months, the questionnaire and oral health status evaluation were repeated. After 6 months, subjects returned for final clinical evaluations and intraoral photographs. A routine dental prophylaxis was administered, oral health status was assessed by a dental hygienist, and subjects were discharged from the study. The test products were two rinses. The experimental group was a high bioavailable 0.07% CPC therapeutic mouthrinse in a blue mint-flavored, alcohol-free base. The control group was a low bioavailable 0.045% CPC mouthrinse in a green, mint-flavored, 15% alcohol base. In addition to the apparent color differences, these two rinses differed considerably in CPC availability 30 with approximately a two-fold increase in available CPC in the therapeutic rinse relative to the control. In clinical trials, the therapeutic rinse is reported to have significant antiplaque and antigingivitis benefits 30 while the control is recognized as having pleasant in-use characteristics. Test products were dispensed blind as to treatment assignment. Rinses were supplied in clear, 1.5 L stock mouthrinse bottles. Each bottle carried an investigational study label with warnings (e.g.: “do not swallow”) and contact numbers. Rinse bottles were packaged in a cardboard kit box, along with instructions for use. Supplemental mouthrinse was shipped directly to subjects upon request. In this “real world” study, subjects were not supplied with a standard dentifrice, toothbrush, or other oral hygiene products. Subjects were asked to suspend use of non-study mouthrinses for the duration of the research. Label instructions specified twice daily rinsing as part of routine oral hygiene practices following manufacturer’s instructions for use. All rinsing was unsupervised. A subject questionnaire was administered at baseline, and again after 3 and 6 months. Subjects were specifically questioned on rinsing frequency, and open-ended questions were designed to elicit likes and dislikes, including side effects, during the 6-month treatment period. At study completion, rinses were assessed in five areas: taste, appearance, ease of use, burning and aftertaste, using a 5-point ordinal scale. Oral health status was evaluated by one of 12 dental hygienists at baseline, 3 and 6 months. The baseline evaluation was conducted using a standard full mouth dental chart and instrumentation. Each hygienist was asked to evaluate calculus, stain/discoloration, and other oral conditions using a categorical 5-point scale. To model practice conditions, the baseline chart was available at the 6-month hygienist evaluation. Demographic and behavioral parameters were summarized by group. Between-group comparisons in compliance, acceptability and clinical evaluations, all of which were ordinal in nature, were tested using the Wilcoxon Rank Sum test. Exact P-values were calculated. All testing was twosided at a 0.05 level of significance. Results A total of 308 subjects were assigned a test product (143 in the therapeutic rinse and 165 in the cosmetic rinse). Of these, 277 (90%) had a 3-month evaluation, and 273 (89%)
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Page 5 and 6: 4A White Fig. 2. Mechanical hygiene
Page 7 and 8: 6A White Oral pain subjective index
Page 9 and 10: 8A White 1997; 76 :357 (Abstr 2749)
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